Intravenous catheter assembly

ABSTRACT

An intravenous catheter assembly comprising: a catheter tube; a catheter hub having a distal end and a proximal end, wherein the distal end is joined to the catheter tube and the proximal end defines a housing having inner space; a needle extending through the catheter hub and the catheter tube and defining an axial direction, wherein the needle has opposite proximal and distal ends, the distal end forming a needle tip; a needle hub attached to the proximal end of the needle; a needle guard slidably arranged on the needle, wherein the needle guard is movably retained in the housing of the catheter hub; a valve provided in the inner space in the catheter hub to prevent foreign contamination from entering the catheter hub; and a disc that is arranged proximal or distal to the valve or that is joint or linked to the valve.

CROSS-REFERENCE TO PRIORITY APPLICATION

This application is a continuation of U.S. patent application Ser. No.16/604,413 for INTRAVENOUS CATHETER ASSEMBLY, filed Oct. 10, 2019, whichitself claims the benefit of PCT Patent Application No.PCT/1B2019/051757 for INTRAVENOUS CATHETER ASSEMBLY, filed Mar. 5, 2019,which itself claims the benefit of India Patent Application No.201811008072 INTRAVENOUS CATHETER ASSEMBLY, filed Mar. 5, 2018. Each ofthe foregoing patent applications are hereby incorporated by referencein its entirety.

FIELD OF THE INVENTION

The invention generally relates to intravenous catheter assemblies. Moreparticularly, the invention relates to an intravenous catheter assemblycomprising a catheter hub arranged at a proximal end of a catheter tubeand having an inner space defining a housing; a needle having a needletip attached to a needle hub having inner space defining a housing andextending through both the housings and the catheter tube when in aready position.

BACKGROUND OF THE INVENTION

An intravenous catheter assembly of this kind is generally known.Catheter assemblies are used to place a catheter properly into thevascular system of a patient. Once in place, catheters such asintravenous (“IV”) catheters may be used to infuse fluids includingnormal saline, medicinal compounds, and/or nutritional compositions orthe like into a patient in need of such treatment. Cathetersadditionally enable the removal of fluids from the circulatory systemand monitoring of conditions within the vascular system of the patient.

One type of commonly used catheter is a peripheral intravenous catheterwhich are indwelling intravenous catheters often used to provide anentry route for medications, fluid for hydration, and in some cases, forparenteral feeding, into a patient. Such catheters are generally shortin length, ranging from about one-half to about three inches in length,and are generally made of flexible biocompatible materials. Peripheralintravenous catheters are often provided as “over-the-needle” cathetersmounted over an introducer needle with a sharp distal tip. A portion ofthe catheter including at least the distal tip of the catheter securelygrips the outside of the needle to prevent catheter peelback duringinsertion of the catheter into the circulatory system of the patient.Although several techniques for placing such catheters are practiced inthe art, many generally include the step of inserting at least a portionof the needle into the target vessel and then sliding the catheter overthe needle into place.

Once placement of the needle has been confirmed, the medical personnelmay remove the needle, leaving the catheter in place. A septum withinthe catheter housing can prevent the outflow of fluid during andfollowing removal of the introducer needle. These septum structures aregenerally elastomeric and are designed to closely conform to the shapeof a needle during storage and use to prevent leaking, then to seal uponremoval of the needle. However, if the needle is left within the septumfor long periods, the septum may not completely seal after the needle isremoved, having conformed, in part, to the shape of the withdrawnneedle. An incompletely sealed septum can increase the risk of bloodexposure to medical personnel, since blood may flow through the smallopening in the slit of the septum. It would thus be an improvement inthe art to provide a catheter assembly with more reliable sealingfunctionality. Such a catheter assembly is disclosed herein.

The catheter assembly is also provided with a needle guard slidablyarranged on the needle and received in the housing when the needle is inits ready position, wherein the needle guard is configured to guard theneedle tip upon withdrawal of the needle from the catheter hub.

The needle guard serves to prevent a person handling the intravenouscatheter apparatus from accidentally coming into contact with the needletip after placement of the catheter tube in and subsequent removal ofthe needle from a patient's vein. Thereby, the intravenous catheterapparatus helps to avoid unwanted transmission of blood borne diseases.

According to one of the embodiments of the invention, the catheter huband/or needle hub within which the needle guard is received in a readyposition includes holding means for holding the needle guard even underretracting forces acting on the needle guard when the needle isretracted out of the patient's vein. These holding means may include oneor more depressions formed on the inner circumferential surface of thecatheter hub and/or needle hub into which one or more protrusions formedon the first and second arm of the needle guard securely engages in theready position. For example, when the first arm is deflected and spreadapart from the second arm by the needle shaft.

SUMMARY AND OBJECTS OF THE INVENTION

A primary object and advantage of the present invention is to provide animproved intravenous catheter assembly which is inexpensive tomanufacture, efficient, effective and simple in its construction anduse.

It is another object of the present invention to provide an intravenouscatheter assembly which provides better protection against accidentalpricking by the needle tip and which is inexpensive to manufacture atthe same time.

It is another object of the present invention to provide an intravenouscatheter assembly with improved safety features having a needle guardslidably arranged on the needle and received in the hub when the needleis in its ready position, wherein the needle guard is configured toguard the needle tip upon withdrawal of the needle from the hub.

It is another object of the present invention to provide an intravenouscatheter assembly which has better blood control features.

It is another object of the present invention to provide a compactdesign for housing one or more valves within the catheter hub housing ofthe intravenous catheter assembly having better blood control features.

According to one of the embodiments, the present invention relates to anintravenous catheter assembly comprising: a catheter tube; a catheterhub having a distal section and a proximal section, wherein the distalsection is joined to the catheter tube and the proximal section definesa housing; a port provided on the catheter hub forming an opening intothe inner space covered by a port cap, a needle extending through thecatheter hub and the catheter tube and defining an axial direction,wherein the needle has opposite proximal and distal ends, the distal endforming a needle tip; a needle hub attached to the proximal end of theneedle. The hub is also provided with wings which in use may beadhesively taped to the skin of the patient at the venipuncture site tomaintain the device stationery during the infusion.

The port in the catheter assembly forms an opening into the inner spacewhich can be covered by a port cap. In one of the embodiments, a firstvalve is provided adjacent to the port opening that provides selectiveaccess through the port. Fluid may be infused and withdrawn from thecatheter through the port without the problem of leakage/outflow or riskof blood exposure. Thus, the port forms a first fluid path from theexternal environment into the inner space of the catheter assembly. Thefirst valve provided in the first flow path further provides the abilityto infuse and withdraw liquids through the port. Thus, the valve on orin the port provides a number of benefits when used with bloodcontrol-type catheter assemblies.

The catheter assembly is also provided with a second valve in the innerspace which selectively seals a proximal end of the inner space of thecatheter housing. Placing the second valve in the catheter hub avoidsthe problems of outflow of fluid for example, when the second valve isin the path of an introducer needle in the inner space of the catheterhub. The second valve is configured with a plug which is also housed inthe inner space of the catheter hub.

Accordingly, in some implementations of the invention, the first valveadjacent to the port opening is utilized with a catheter assembly havingan internal blood control second valve (also named second valve). Thesecond valve can include a blood control septum. The blood controlseptum is provided to allow selective flow of fluid through the fluidpathway. For example, the blood control septum may include a slit thatmay be bypassed when an external luer device is coupled to the hub ofthe catheter assembly and directly engaging the septum. Upon removingthe external luer device, the slit is closed to prevent blood fromleaking out of the catheter assembly.

A septum activator may also be located within the inner space at alocation that is behind the second valve. When a separate luer device isinserted into the proximal end of the catheter hub, the septum activatoris advanced forward through the blood control septum of the secondvalve, activating the blood control septum. The septum activatorgenerally comprises a tubular body that is rigid or semi-rigid. Thetubular body further comprises an inner lumen for facilitating flow of afluid and/or liquid through the septum activator. The distal end of thetubular body can be shaped and sized to compatibly enter within the oneor more slits of the blood control septum of the second valve.

The valves provided can be of various types which can be incorporatedinto the port and the inner space in the catheter housing to providemedical personnel with the ability to infuse and withdraw fluids fromthe catheter assembly. The valve can be a one-way valve or a two-wayvalve. A two-way valve is a valve that permits fluid flow in twodirections through or around the valve when the valve is open.Non-limiting examples of a two-way valve include a split septum, a ballvalve, and an iris valve or the like. Thus, a two-way valve can permitfluid to be introduced into the catheter assembly (a first way) and tobe withdrawn from the catheter assembly (a second way).

In some embodiments, the valve is a one-way valve, which is a valve thatonly permits substantial fluid flow in a single direction when the valveis open. A non-limiting example of a one-way valve is a check valve.

The valve can be housed inside the port or in the inner space providedin the housing of the catheter assembly. These valve types are notpresented as an exhaustive set of valve types, and thus it will beunderstood that other suitable valves can be utilized in port and thecatheter assembly.

In further embodiments of the invention, the first valve can be locatedon a removable luer access connector that can be connected anddisconnected from the port. Alternatively, the first valve can belocated on a luer access connector that is fixedly connected to theport. The first valve can be a luer access valve that accommodates theinsertion of a luer device, such as those commonly used in the medicalindustry. Moreover, a body portion of the port can include luer threadsor other connecting and/or fastening features that can secure a luerdevice to the catheter assembly.

In some configurations, the port can be disposed at an angle relative tothe longitudinal axis of the catheter in order to modify the directionat which fluids are infused into the inner housing of the catheterassembly. This angle can be between about 10° to about 90°. The angle ofthe port can be modified to facilitate use, optimize performance, and/oroptimize fluid flow within the inner space of the catheter assembly.

The embodiments of the present invention also include the provisions forincluding a needle guard slidably arranged on the needle, wherein theneedle guard is movably retained in the housing of the catheter hub whenthe needle extends through the catheter hub and the catheter tube, andwherein the needle guard is removable from the catheter hub once theneedle tip is received in the needle guard upon withdrawal of the needlefrom the catheter tube; and wherein the housing defines a chamber at oneend thereof ensuring that a first and second arms of the needle guard donot engage or interact with an inner surface of the chamber prior andduring venipuncture of a patient. An intravenous catheter assembly ofthis kind is generally known. The needle guard serves to prevent aperson handling the intravenous catheter apparatus from accidentallycoming into contact with the needle tip after placement of the cathetertube in and subsequent removal of the needle from a patient's vein.Thereby, the intravenous catheter assembly helps to avoid unwantedtransmission of blood borne diseases.

As well known in the art, the needle may also have a needle featureclose to its needle tip, which interacts with a proportional base of theneedle guard, e.g., a curving or a bulge or crimp any other change inprofile. Thereby, it can be prevented that the needle is retracted outof the needle guard, which is known in the art.

In an embodiment, the catheter hub is made of two parts. The first andsecond parts being joined together define the housing having an innerspace. The first and second part may form the housing, in particular,the distal end section of the first part and the proximal end section ofthe second part may form the housing, which ensures that no undercut hasto be formed in either one of the first and second part.

Further, the first part includes the port defining a first flow path.Alternatively, it is also possible to provide the port on the secondpart. The first and second parts of the catheter hub may be joined bycomplementary end portions, which preferably as such extend at an anglewith regard to the axial direction. This ensures that both parts arealigned concentrically towards each other. Thereby, the assembly of sucha catheter hub can be made easier. These end portions may be stepped,which enlarges their contact area for a better mutual interconnection.

In an embodiment, the inner space of the catheter hub may receive aneedle guard which is movably arranged on the needle shaft. The chambermay be formed by an indentation in the housing for accommodating thefirst and second arm such that none of the arms deflected by the needlecontacts an inner surface of the chamber. Through such indentation theoverall outer dimensions of the housing and the catheter hub can be keptsmall, which it is still provided that the first arm and second arm ofthe needle guard do not contact the inner wall surface of the chamber.

The inner space of the housing may be parallel to the axial directionand defined by the distal end section of the first part and the proximalend section of the second part of the catheter hub. Alternatively, theinner space of the housing is defined only by one of the first or secondpart i.e., by either the distal end section of the first part or theproximal end section of the second part. Further alternatively, theinner space of the housing is defined by the proximal end section of thesecond part. The advantage in this lies in the fact that only one of thetwo parts forming the catheter hub has to be dimensioned very preciselyin order to ensure an inner space with a well-controlled and largeenough diameter such that none of the arms of the needle guard whenhoused in the inner space of the catheter hub contact said innersurface. In this regard, it is advantageous that the inner space of thehousing is defined by the first and second part comprising the secondfluid path.

According to one of the embodiments of the invention, one of the firstor second part of the catheter hub comprises a surface joined with theinner surface of the one of the first or second part, which surface isinclined towards the inside of the housing in a proximal direction ofthe catheter hub, wherein the surface has a smaller inside diameter atits innermost end than a distance between outermost points of the armsin their deflected state inside the chamber. Preferably, the first partcomprises the surface joined with the inner surface of the second part.Preferably, the distal end section of the first part comprises thesurface joined with the inner surface of the proximal end section of thesecond part. Such a surface serves as a stop for the arms of the needleguard when housed in the inner space of the catheter hub in theirdeflected state such that they cannot be pulled out of the catheter hubin the proximal axial direction as long as the needle deflects themoutward in the ready position of the needle guard. On the other hand,the inclination of the surface supports that the arms are directedinwards when the needle guard is pulled out in the retracted position,even if they have been plastically deformed by the needle in theirdeflected state.

In some embodiments, an antimicrobial coating is applied to one or moresurfaces of the intravenous catheter assembly. The antimicrobial coatingfurther includes an antimicrobial agent that is compatible for use inintravenous catheter assembly used for infusion therapy. Non-limitingexamples of suitable antimicrobial agents include chlorhexidinediacetate, chlorhexidine gluconate, alexidine, silver sulfadiazine,silver acetate, silver citrate hydrate, cetrimide, cetyl pyridiumchloride, benzalkonium chloride, o-phthalaldehyde, and silver element.

Accordingly, one of the embodiments of the present invention relates toan intravenous catheter assembly comprising: a catheter tube; a catheterhub having a distal end and a proximal end, wherein the distal end isjoined to the catheter tube and the proximal end defines a housinghaving inner space; a needle extending through the catheter hub and thecatheter tube and defining an axial direction (A), wherein the needlehas opposite proximal and distal ends, the distal end forming a needletip; a port extending outwardly in a direction perpendicular to theaxial direction (A) from a sidewall of the catheter hub; a needle hubattached to the proximal end of the needle; a first valve provided inthe inner space in the catheter hub to prevent foreign contaminationfrom entering the catheter hub; a blood control second valve arrangedwithin the inner space of catheter hub to prevent the outflow of fluidduring and following removal of the needle wherein the second valveconfigured with a plug also housed in the inner space of the catheterhub.

One of the embodiments of the present invention relates to anintravenous catheter assembly comprising: a catheter tube; a catheterhub having a distal end and a proximal end, wherein the distal end isjoined to the catheter tube and the proximal end defines a housinghaving inner space; a needle extending through the catheter hub and thecatheter tube and defining an axial direction (A), wherein the needlehas opposite proximal and distal ends, the distal end forming a needletip; a port extending outwardly in a direction perpendicular to theaxial direction (A) from a sidewall of the catheter hub a needle hubattached to the proximal end of the needle having a housing; a needleguard slidably arranged on the needle, wherein the needle guard ismovably retained in a needle guard casing and the needle guard casing ismovably retained in the housing of the needle hub, when the needleextends through the needle hub, catheter hub and the catheter tube,wherein the needle guard is removable from the needle hub being retainedin the needle guard casing and then the needle tip is received in theneedle guard upon withdrawal of the needle from the catheter tube.

One of the embodiments of the present invention relates to anintravenous catheter assembly comprising: a catheter tube; a catheterhub having a distal end and a proximal end, wherein the distal end isjoined to the catheter tube and the proximal end defines a housinghaving inner space; a needle extending through the catheter hub and thecatheter tube and defining an axial direction (A), wherein the needlehas opposite proximal and distal ends, the distal end forming a needletip; a port extending outwardly in a direction perpendicular to theaxial direction (A) from a sidewall of the catheter hub; a needle hubattached to the proximal end of the needle having a housing; a needleguard slidably arranged on the needle and an upper end of the needleguard is securely retained in the housing of the catheter hub exposingthe lower end of the needle guard and wherein in the ready to useposition, the entire catheter hub portion with the lower end of theneedle guard is securely retained in an inner space of the needle hub.

Some embodiments of the present invention further comprise one or moremethods for manufacturing an intravenous catheter assembly according tothe teachings of the instant invention. For example, in at least oneembodiment a method of manufacturing is provided comprising thefollowing steps: 1) providing catheter assembly having a catheter hubwhich has a proximal end, a distal end and an inner space extendingtherebetween; 2) placing a side port on a sidewall of the catheter huband forming a pathway through the sidewall of the catheter hub and incommunication with the inner space; 3) disposing a first valve withinthe inner space and forming a seal between the inner space and thepathway of the side port; and 4) disposing a blood control second valvewithin the inner space and dividing the inner space into a proximalchamber and a distal chamber. In some instances, a further step isprovided for providing a needle guard for securely covering the needletip once withdrawn from the patient in order to prevent accidentalpricking. The needle guard can be housed in the catheter hub or theneedle hub or in part within the catheter hub or in part within theneedle hub or in part both within the catheter hub or needle hub orwithin a needle guard casing. Alternatively, a needle guard can belocated outside of a catheter hub, such as in a separate hub differentfrom the catheter hub and needle hub. The needle guard of the presentdisclosure may embody any number or type of prior art guards configuredfor blocking or covering the needle tip of the needle in protectedposition.

Some embodiments of the present invention further comprise a discarranged proximate to the first valve, the second valve, or both thefirst and the second valve.

The disc can be configured to hold the valve in its position. The disccan be configured such that at a high pressure, the valve arrangedproximate to the disc does not displace from its position.

Some embodiments of the present invention further comprise a cut in theproximal end of the catheter hub. The cut may support locking of thecatheter hub with the needle hub. The cut may further restrict therotation of the catheter hub with respect to the needle hub. The cut mayalso be configured to reduce the withdrawal force required to withdrawthe needle hub from the catheter hub.

Some embodiments of the present invention further comprise a proximalneedle feature at the proximal end, opposite to the needle tip end. Theproximal needle feature can, in addition to needle fixation means,increase the force required to separate the needle from the needle hub.

Some embodiments of the present invention further comprise at least onewing alignment feature and/or at least one catheter alignment featureconfigured to align and orient the wing with the catheter hub. The atleast one wing alignment feature and/or at least one catheter alignmentfeature can further be configured to prevent distal or proximal movementof the wings with respect to the catheter hub.

Some embodiments of the present invention further comprise at least oneneedle guard engaging element configured to restrict the rotation of theneedle guard. The needle guard may comprise a corresponding needle guardanti-rotation element configured to engage the needle guard engagingelement.

Some embodiments of the present invention further comprise wing membersmade of a soft material, a rigid material, or a combination of a softand a rigid material. The wings may further comprise a window configuredfor air venting.

Some embodiments of the present invention further comprise wings havinga tapered profile. The tapered profile may have an increasing width inproximal direction. The tapered profile can support the alignment of thedevice with a patient's body and can support the insertion of theneedle.

Some embodiments of the present invention further comprise a curvedand/or tapered proximal end of the catheter hub. The curved and/ortapered proximal end may simplify assembly of the catheter hub with theneedle hub.

Some embodiments of the present invention further comprise a portincluding a port hole, the port hole can contribute in directional flowof fluid through the port. The port hole profile and location can bechanged and the specific position and design of the port hole can beconfigured to optimize the flow and pressure balance.

Some embodiments of the present invention may comprise a valvecomprising an elastomeric member having a peripheral wall projectingfrom a base surface. The base surface can comprise at least one slit,which passes through the thickness of the base surface. The elastomericmember can have a lateral annular protrusion from edge of the basesurface configured to be received by a recess (not shown) within aninterior wall of the catheter hub. The lateral annular protrusion cansupport the holding of the valve in the catheter hub.

Some embodiments of the present invention may comprise an inner verticalprojection extending from the base surface of the valve. The innervertical projection may have a rounded shape. The base surface caninclude a second vertical projection extending from the vertical annularprojection. The second vertical projection may have a smaller diameterthan the vertical annular projection.

Some embodiments of the present invention may comprise a valvecomprising at least one slit in the base surface. The valve can compriseat least one center slit, A center slit can support the introduction ofthe needle in the valve and can be configured to seal once the needle iswithdrawn. The valve can comprise at least one outer slit. An outer slitcan contribute towards aspiratory flow, for instance while drawing bloodusing a syringe. The valve can comprise at least one center slit and atleast one outer slit. The center slit can have the form of a hole, aslit, a cross slit, a plus slit, a Y slit, an arc slit, a V slit, or anyother shape. The center slit profile may vary with respect to the shape,size, or orientation of the slit. The center slit may be made in any wayor process. The outer slit may have the form of a slit, a T slit, a Yslit, a V slit, a rounded V slit, an arc slit, or any other shape. Theouter slit profile may vary with respect to the shape, size,orientation, location or number of the at least one slit. The at leastone outer slit may be made in any way or process. The valve may compriseany combination of a central slit and outer slits.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The foregoing and other objects, features, and advantages of theinvention will be apparent from the following detailed description takenin conjunction with the accompanying drawings, wherein:

FIG. 1 illustrates an intravenous catheter assembly according to one ofthe embodiments of the present invention.

FIGS. 2A-2C are different embodiment of the needles according to thepresent invention.

FIG. 3 is a cross-sectional side view of the two parts forming acatheter hub of the intravenous catheter assembly according to one ofthe embodiments of the present invention.

FIG. 4A is a cross-sectional side view of the intravenous catheterassembly showing a side port, a catheter hub, a needle hub and a needleguard casing with a needle guard retained in the needle hub according toone of the embodiments of the present invention.

FIG. 4B is a cross-sectional side view of the needle guard of thepresent invention.

FIG. 4C is a cross-sectional side view of the intravenous catheterassembly showing a catheter hub, a needle hub and a needle guard casingwith a needle guard retained in the needle hub according to one of theembodiments of the present invention.

FIG. 4D is a cross-sectional side view of the intravenous catheterassembly showing a catheter hub, a needle hub and a needle guard casingwith a needle guard retained in the needle hub according to one of theembodiments of the present invention.

FIG. 5A is a perspective view of the needle guard casing of the presentinvention.

FIG. 5B is a cross-sectional side view of the needle guard casingshowing a needle guard housed within according to one of the embodimentsof the present invention.

FIG. 5C is a perspective view of the upper part of the needle guardcasing of the present invention.

FIG. 5D is a perspective view of the lower part of the needle guardcasing of the present invention.

FIGS. 6A & 6B are perspective views of the needle hub of the intravenouscatheter assembly according to one of the embodiments of the presentinvention.

FIGS. 7A & 7B are a cross-sectional side views of the intravenouscatheter assembly showing a catheter hub, a needle hub and a needleguard retained in the needle hub and catheter hub according to one ofthe embodiments of the present invention.

FIGS. 8A-8E are views of a disc and second valve that can be used incombination with any of the catheter assemblies described in the presentinvention.

FIGS. 9A and 9B are views of a cut at the proximal end of a catheter hubthat can be used in combination with any of the catheter assembliesdescribed in the present invention.

FIGS. 10A, 10B and 10C are views of proximal needle feature that can beused in combination with any of the catheter assemblies described in thepresent invention.

FIGS. 11A, 11B, 11C and 11D are views a wing alignment feature and acatheter hub alignment feature that can be used in combination with anyof the catheter assemblies described in the present invention.

FIGS. 12A and 12B are views of a needle guard engaging element that canbe used in combination with any of the catheter assemblies described inthe present invention.

FIGS. 13A and 13B are views of the wing members that can be used incombination with any of the catheter assemblies described in the presentinvention.

FIGS. 14A and 14B are views of a tapered profile of the wings that canbe used in combination with any of the catheter assemblies described inthe present invention.

FIG. 15 is a view of a curved/tapered proximal end of the catheter hubthat can be used in combination with any of the catheter assembliesdescribed in the present invention.

FIGS. 16A and 16B are views of a port hole of the port that can be usedin combination with any of the catheter assemblies described in thepresent invention.

FIGS. 17A, 17B, 17C, 17D, 17E, and 17F are views of differentconfigurations of a valve that can be used in combination with any ofthe catheter assemblies described in the present invention.

FIGS. 18A, 18B 18C, 18D and 18E are views of slits of the valve that canbe used in combination with any of the catheter assemblies described inthe present invention.

FIGS. 19A and 19B, are views of the disc being joint to the valve thatcan be used in combination with any of the catheter assemblies describedin the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Embodiments of the presently disclosed invention will now be describedin detail with reference to the drawings wherein like reference numeralsdesignate identical or corresponding elements. In the drawings and inthe description, the term “proximal”, “top”, “up” or “upper” refers to alocation on the device that is closest to the clinician using the deviceand farthest from the patient in connection with whom the device is usedwhen the device is used in its normal operation. Conversely, the term“distal”, “bottom”, “down” or “lower” refers to a location on the devicethat is farthest from the clinician using the device and closest to thepatient in connection with whom the device is used when the device isused in its normal operation. For example, the distal region of a needlewill be the region of the needle containing the needle tip which is tobe inserted, e.g., into a patient's vein.

As used herein, the term “in” or “inwardly” or “inner” refers to alocation with respect to the device that, during normal use, is theinside of the device. Conversely, as used herein, the term “out” or“outwardly” or “outer” refers to a location with respect to the devicethat, during normal use, is toward the outside of the device.

As used herein, the terms first, second, third, etc. are understood todescribe different structures so as to distinguish one from another.However, the terms are not structurally limiting unless the contextindicates otherwise.

The term “substantially” means that the recited characteristic,parameter, or value need not be achieved exactly, but that deviations orvariations, including for example, tolerances, measurement error,measurement accuracy limitations and other factors known to those ofskill in the art, may occur in amounts that do not preclude the effectthe characteristic was intended to provide.

Moreover, the Figures may show simplified or partial views, and thedimensions of elements in the Figures may be exaggerated or otherwisenot in proportion for clarity. In addition, the singular forms “a,”“an,” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, reference to a terminal includesreference to one or more terminals. In addition, where reference is madeto a list of elements (e.g., elements a, b, c), such reference isintended to include any one of the listed elements by itself, anycombination of less than all of the listed elements, and/or acombination of all of the listed elements.

As used herein “ready position” means the catheter assembly is ready foruse, such as to perform a venipuncture or intravenous access. Sometimesthe ready position first requires removing a protective cap from thecatheter assembly or needle assembly. The protective cap can be includedfor packaging.

As used herein “protected position” means the catheter assembly inparticular the needle hub having a needle is ready for disposal in thatthe needle tip is safely guarded by a needle guard.

Referring to FIG. 1 an intravenous catheter assembly 410 in accordancewith one of the embodiments of the invention is illustrated. Theintravenous catheter assembly 410 generally comprises various featuresand elements to enable intravenous infusion of a fluid or medicamentinto a patient. In some instances, intravenous catheter assembly 410further comprises features to enable removal of a fluid from a patient,such as blood. The intravenous catheter assembly 410 includes a catheterhub 412 having a first fluid path 411 a and a second fluid path 411 b, acatheter tube 414 and a needle 420 attached to a needle hub 416. Thecatheter hub 412 has a distal end 422 and a proximal end 424, whereinthe catheter tube 414 is arranged adjacent to the distal end 422 of thecatheter hub 412, for instance with a slip ring 461. The catheter tube414 can generally include a biocompatible material that is made of aflexible or a semi-flexible polymer. The catheter tube 414 and thecatheter assembly 410 may be integrally coupled such that an inner spacedefining a housing 448 of the catheter hub 412 extends into the cathetertube 414. The catheter hub 412 may also be provided with wings 462 whichin use may be adhesively taped to the skin of the patient at thevenipuncture site to maintain the catheter assembly/device 410stationery during the infusion.

Referring now to FIGS. 2A to 2C, the needle 420 has a needle shaft 428,a needle tip 454 at a distal section 463 of the needle shaft 428 and aneedle hub 416 attached to a proximal section 436 of the needle shaft428. An enlargement 496 of the needle 420 can be provided between thedistal section 463 and the proximal section 436 of the needle shaft 428.The enlargement 496 can have a maximum dimension in a directiontransverse to the needle shaft 428, which is greater than the outerdiameter of the distal 463 or proximal section 436. The enlargement 496can be made, for example, by crimping the needle shaft 428. The crimpmay be made by a local depression 498 such that lateralprotrusions/enlargement 496 result from the crimping process. Thecrimping process may be controlled such that the internalcross-sectional area of the needle 420 is not reduced substantially suchthat the through bore or the internal profile of the needle 420 is notaffected. Prior to use of the catheter assembly 410, the needle 420 isreceived in the catheter hub 412 and catheter tube 414, such that theneedle shaft 428 extends through the length of the catheter tube 414 andthe needle tip 454 is exposed out of the catheter tip. The needle 420 iscapable of piercing the skin to provide access to the vasculature orsubcutaneous tissues of the patient. Once access is obtained, tip ofcatheter 414 is inserted through the newly formed opening and into thedesired location within the patient. The needle 420 is then withdrawnfrom the catheter assembly 410, and catheter 414 is left disposed withinthe patient.

The needle 420 may comprise at least one opening 497 covered by thetubular catheter 414. The opening 497 can provide communication betweena lumen of the needle 420 and an interior of the tubular catheter 414.In the event of first venipuncture blood entering the lumen of theneedle 420 can exit the needle 420 through the opening 497 and thusbecome visible for the person handling. The opening 497 is preferablylarge enough in order to provide an early blood flashback functionwithin the tubular catheter 414 such that the practitioner can recognizethat he has placed the needle 420 correctly within a patient's vein. Incase of a correct positioning of the needle 420, blood pours out of theopening 497 within the needle shaft 428 into the space between theneedle shaft 428 and the inner wall of the transparent tubular catheter414 and is visible to the practitioner. Preferably, the opening 497 ispositioned close to the needle tip 454 so that the blood does not haveto travel the length of the needle 420 to enter the needle hub 416 inorder to become visible. Instead, blood entering the lumen of the needle420 upon venipuncture partly exits the needle 420 near the needle tip454, thereby becoming particularly quickly and, thus, allowing forparticularly fast venipuncture confirmation. The opening 497 may have aminiscule size which serves the purpose of early flashback detection andwhich does not obstruct the arms of the needle guard 426.

The opening 497 can be provided before or after the enlargement 496. Infurther embodiments of the invention, the needle 420 may also be formedwith the opening 497 arranged distally or proximally from theenlargement 496. The opening 497 may be formed by a small slit which iscut into the needle shaft 428 and which extends in axial direction A forabout a small distance. The opening 497 may be just large enough inorder to provide an early blood flashback function close to the needletip 454 within the catheter tube 414 such that the practitioner canrecognize that he has placed the needle 420 correctly within a patient'svein. In case of a correct positioning of the needle 420, blood poursout of the opening 497 within the needle shaft 428 into the spacebetween the needle shaft 428 and the inner wall of the transparentcatheter tube 414 and is visible to the practitioner.

Referring now to FIG. 3 , the catheter hub 412 is made of two parts,i.e., a first part 412 a and a second part 412 b. The first part 412 ahas a distal end section 450 and the second part 412 b has a proximalend section 452. The distal end 422 of the second part 412 b isconnected to a catheter tube 414. The distal end section 450 of thefirst part 412 a is configured to be assembled with the proximal endsection 452 of the second part 412 b in various ways in a fluid tightmanner, such as by adhesive sealing, ultrasonic welding, heated die,radio frequency sealing, mechanical seal (snap fit), insert molding,laser welding etc., ensuring a leak free joint. It is also possible tojoin the two parts 412 a, 412 b to one another, for example, usingthreads, interference, or snap-fit. In particular, as can be seen inFIG. 3 , the first and second parts 412 a and 412 b are joined bycomplementary stepped end portions/surfaces 457, 459.

A port 464 includes a port body having one or more integrated bodyportions which extend outwardly in a direction perpendicular to theaxial direction A from the sidewall 470 of the catheter hub 412. Theport 464 has an opening 465 defining an inlet and a bore 466 extendingbetween the inlet and the opening 468 of the inner space 467 of thecatheter hub 412. The port 464 and in particular, the inlet 465 and atleast a portion of bore 466 is shaped and sized in conformity with theprescribed International Standards Organization (ISO) standards for afemale luer connection. This will allow a male luer slip or male luerlock to be connected to port 464. The port 464 is covered with a portcap 469.

The port 464 can be a side port or a top port. Fluids may be infused andwithdrawn from the catheter assembly 410 through the port 464 in asidewall 470 of the catheter hub.412. The sidewall 470 can be any wallof the catheter hub 412 that extends substantially axially along thecatheter tube 414.

In various embodiments, the outer periphery and/or inner periphery ofthe port 464 body can include one or more luer threads or the like inany number of thread configurations available to provide and interlockbetween mating devices. The luer threads allow another medical devicehaving a male luer lock to be connected to and interlocked with the port464. Alternatively, the port 464 body can also have no luer threads toaccommodate luer slip and luer lock connections.

A first valve 471 may be provided in an inner space 467 adjacent to aninlet opening 468 in the catheter hub 412 to prevent foreigncontamination from entering the catheter hub 412 that provides selectiveaccess through the port 464. The first valve 471 may include anelastomeric septum 472 having at least one slit that can form a fluidbarrier until the septum deforms to allow fluid flow there through. Slitprovides a fluid-tight seal, thereby preventing fluid from bypassingseptum 472. The first valve 471 may generally comprise a flexible tubehaving an outer diameter that is approximately the same size as an innerdiameter of the inner space 467 of the catheter hub 412, whereby thefirst valve 471 may be retained within the inner space 467 by aninterference fit or by means of change of dimensions.

The first valve 471 can be located on the inlet 465, within the inlet465, adjacent to the inlet 465, within the bore 466 of the port body 464or in the inner space 467 adjacent to the inlet opening 468 in thecatheter hub 412. As shown in FIG. 4A, the first valve 471 is arrangedwithin the bore 466 of the port body 464.

First valve 471 may generally comprise a resilient, flexible materialthat is easily deformed when fluid is introduced to port 464 via asyringe or other compatible device. Materials such as silicone, siliconerubber, or polyisoprene or the like can be used to form the first valve471. The first valve 471 can be formed as a single piece of elastomericmaterial that is formed to having various shapes and features.Alternatively, the first valve 471 can be a two-piece configurationhaving a flexible inner material, such as silicon or silicone rubber,and a more rigid outer portion, such as an outer ring. The outer ringcan be formed of a plastic or metal or other suitable material. Thefirst valve 471 includes at least one slit. Alternatively, first valve471 can include a plurality of slits. In some configurations, at least aportion of the first valve 471 is glued to the port body 464 using oneor more adhesives in a fluid tight manner. Additionally oralternatively, in some configurations, at least a portion of the firstvalve 471 is held in place between two or more portions of the port body464 in a fluid tight manner.

The port 464 can be accessed, with a male luer device that is insertedthrough the slit of the first valve 471. The male luer device can beinterlocked with the luer threads if the male luer device includes aluer lock. In this manner, a separate access device can be coupled tothe catheter assembly 410 through the port 464 to establish fluidcommunication there through. Additionally, a syringe, needle, or othersuch device can be inserted through the slit of the first valve 471 towithdraw fluids there through. Using the first valve 471, medicalpersonnel can access the inner space 467 of the catheter hub 412 withoutbeing exposed to the patient's blood.

A blood control second valve 473 including a blood control septum 474having at least one slit may be arranged within the inner space 467 ofcatheter hub 412 to prevent the outflow of fluid during and followingremoval of the needle 420. The second valve 473 can be configured with aplug 475 which is also housed in the inner space 467 of the catheter hub412. The blood control second valve 473 can be elastomeric and bedesigned to closely conform to the shape of a needle 420 to preventleaking. The blood control second valve 473 can also seal upon removalof the needle 420 due to axial compression forces on the second valve473 that induces the second valve to close. The second valve 473 canhave an outer diameter that is configured to compatibly seat within agroove or channel or other suitable projections formed on an innersurface 456 of the catheter hub 412. Alternatively, a valve receivingmeans such as a groove or channel or other suitable projections can beformed on the outer surface 458 of the second valve 473, whichinterlocks with one or more features on the inner surface 456 of thecatheter hub 412.

The second valve 473 can be configured with a plug 475 which is alsohoused in the inner space 467 of the catheter hub 412. The plug 475 isin fluid communication with the second valve 473 and inner space 467 ofthe catheter hub 412. The inner surface at a distal end 422 of thesecond valve 473 can be provided with at least one projection or grooveor vice versa matching with said at least one projection or grooveprovided in an outer wall/surface 458 of the plug 475 at a proximal end424 thereof. Accordingly, the inner surface at a distal end 422 of thesecond valve 473 can be provided with at least one projection matchingwith at least one groove provided in an outer wall/surface 458 of theplug 475 at a proximal end 424 thereof, or the inner surface at a distalend 422 of the second valve 473 can be provided with at least one groovematching with at least one projection provided in an outer wall/surface458 of the plug 475 at a proximal end 424 thereof. The plug 475 may bemade from a first material, e.g., a rigid plastic material or metal, andthe second valve 473 may be made from a second material different fromsaid first material for example, second material of the second valve 473may be resilient, flexible material that is easily deformed when fluidis introduced to port via a syringe or other compatible device.Materials such as silicone, silicone rubber, or polyisoprene or the likecan be used to form the second valve 473. The second valve 473 can bespaced from the first valve 471 being positioned within a fluid pathwaythrough the inner space 467 of the hub 412 of the catheter assembly 410.

In some embodiments, the second valve 473 is tube or barrel shaped,while in other configurations, the second valve 473 is substantiallycylindrical or disk shaped. The embodiments of the second valve 473include other geometrical shapes and dimensions. The second valve 473can be elastomeric and include one or more slits through which a septumactivator can be inserted. The second valve 473 can include at least oneslit. Alternatively, second valve 473 can include a plurality of slits.Slit can provide a fluid-tight seal, thereby preventing fluid frombypassing septum 474.

The proximal end 424 of the catheter hub 412 further comprises anopening 477 through which a separate secondary device may be inserted toinfuse and withdraw fluid and/or liquid, such as a syringe orintravenous fluid line. In some instances, proximal end 424 comprises aset of threads configured to threadedly receive the secondary device ina secure manner. Opening 477 may further comprise a tapered opening toreceive secondary device via an interference or friction fit. Proximalend 424 and opening 477 may alternatively comprise various surfaces andother features to enable coupling to a needle hub 416, a diagnosticdevice, and other suitable infusion therapy equipment.

As discussed above, upon deformation of the first valve 471 and secondvalve 473, fluid from the syringe or from the patient is permitted tobypass the deformed valve and flow into inner space 467 of the catheterhub 412. As the fluid pressure decreases, the resilient nature of thevalve's 471, 473 material causes valves 471, 473 to restore theiroriginal shape, thereby once again blocking the fluid pathway. In someembodiments, valves 471, 473 may be secured within inner space 467 ofthe catheter hub 412 by any compatible means. For example, valves 471,473 are secured within inner space 467 via an adhesive. In otherembodiments, valves 471, 473 are secured within inner space 467 via aninterference fit. Further, in some instances valves 471, 473 areinserted into an annular groove formed on the inner surface of thecatheter hub 412. For example, the first valve 471 as shown in FIG. 3 .is placed within inner space 467 so as to overlap and form a sealbetween inner space 467 and the pathway of the port 464. Both the first471 and second 473 valves comprise a proximal opening, a distal opening,and a pathway extending therebetween. In some instances, proximalopening comprises a reduced diameter. The embodiment shown in FIG. 3 iswithout a needle guard 426. However, a needle guard 426 can be housedwithin the housing of catheter hub 412 and/or needle hub 416.

In another embodiment, as shown in FIG. 4A a needle guard 426 as shownin FIG. 4B is movably arranged on the needle shaft 428 and retained in aneedle guard casing 478. The needle guard casing 478 can be movablyretained in the needle hub 416 prior to use of the catheter assembly 410as shown in FIGS. 4A, 4C & 4D. The needle hub 416 is provided with innerspace 479 defining a housing to movably receive the needle guard casing478 as shown in FIGS. 6A and 6B. The needle guard casing 478 has asubstantially cylindrical shape, which is structurally beneficial to theprovision of rotation capabilities.

Referring now to FIGS. 5A to 5D, the needle guard casing 478 comprisesan upper part 482 and a lower part 483 together forming a chamber 476for housing the needle guard 426. The upper part 482 of the needle guardcasing 478 is received on the lower part 483. For example, the upperpart 482 may be snap-fitted on the lower part 483. The snap-fit may beformed by a protrusion ring 484 and a corresponding groove ring 485 andwhich can be provided in both upper and lower part alternatively. Theprotrusion ring 484 may comprise the grooves and the groove ring 485 maycomprise at least one projection or vice-versa. The ring of both theprojections or groove can be a continuous ring or a spaced apartformation. Other ways and means for a secure engagement are alsoencompassed.

Both the upper part 482 and lower part 483 of the needle guard casing478 can be provided with a chamber 476 to safely house the needle guard426. In the upper part 482 the chamber 476 is provided in the bottomportion 487 whereas in the lower part 483 the chamber 476 is provided inthe top portion 486. Both the upper part 482 and lower part 483 has abore 488 to receive the needle 420. The inner diameter of the bore 488has a close fit ratio with the outer diameter of the needle 420.

A distal end 422 of the upper part 482 can be provided with a fitment489 which is received in the housing 448 of the catheter hub 412creating a secure connection between the two. The fitment 489 also has abore 488 which allows the needle 420 to pass there through. The innerdiameter of the bore 488 has a close fit ratio with the outer diameterof the needle 420. When the needle guard casing 478 is securedcompletely within the needle hub 416 the fitment 489 remains exposed tobe safely received in the housing 448 of the catheter hub 412. In otherembodiments, for a safe and secure connection between the fitment 489 ofthe upper part 482 and the housing 448 of the catheter hub 412, an outerwall 458 of the catheter hub housing 448 is provided with at least oneprojection 480 or groove 481 or vice versa matching with said at leastone projection 480 or groove 481 may be provided in an inner wall 456adjoining said fitment 489. Thus, the needle guard casing 478 is safelysecured with the catheter hub housing 448 by the means of change indimensions. Alternative arrangements by way of replacing the change ofdimensions within or outside the housing 448 and on the upper part 482of the needle guard casing 478 can also be employed. For example, theupper part 482 of the needle guard casing 478 can be made without thefitment 489 and be snap-fitted with the catheter hub housing 448. Thesnap-fit may be formed by a protrusion ring 484 and a correspondinggroove ring 485. The protrusion ring 484 may comprise the groove and thegroove ring 485 may comprise at least one projection or vice versa. Thering of both the projections or groove can be a continuous ring or aspaced apart formation. Other ways and means for a secure engagement arealso encompassed, for example as shown in FIGS. 4A, 4C & 4D. Further,there is a close fit ratio between the inner diameter of the bore 488provided in the upper 482 and lower part 483 of the needle guard casing478 and outer diameter of the needle 420.

As shown in FIGS. 6A and 6B, in order to enable the needle guard casing478 to fit within the housing 479 of the needle hub 416, an inner wall455 of the needle hub housing 479 can be provided with at least oneprojection 480 and/or groove 481 or vice versa matching with said atleast one projection 480 and/or groove 481 is provided in an outer wall458 of an upper 482 and/or lower 483 part of the needle guard casing478. Thus, the needle guard casing 478 is safely secured within theneedle hub housing 479 by the means of change in dimensions. Alternativearrangements by way of replacing the change of dimensions within thehousing 479 and on the upper 482 and lower 483 part of the needle guardcasing 478 can also be employed.

In another embodiment, as shown in FIGS. 7A & 7B the intravenouscatheter assembly 410 of the invention can comprise a catheter hub 412arranged at a proximal end 424 of a catheter tube 414 and defining ahousing 448; a needle 420 defining an axial direction A and having aneedle tip 454, wherein the needle 420 extends through the housing 448and the catheter tube 414 when in a ready position; a needle guard 426slidably arranged on the needle 420 and partly received in the housing448 of the catheter hub 412 when the needle is in its ready position.

As shown, the needle guard 426 is movably arranged on the needle shaft428 and an upper end 490 of the needle guard 426 is securely retained inthe housing 448 of the catheter hub 412 exposing the lower end 491 ofthe needle guard 426. In the ready to use position, the entire catheterhub 412 portion with the lower end 491 of the needle guard 426 issecurely retained in an inner space 479 of the needle hub 416. Theneedle hub 416 is provided with inner space 479 defining a housing tomovably receive the catheter hub 412 and the lower end 491 of the needleguard 426. The housing 479 of the needle hub 416 has a substantiallycylindrical shape, which is structurally beneficial to the provision ofrotation capabilities.

In order to enable the catheter hub 412 to securely fit within thehousing 479 of the needle hub 416, an inner wall 455 of the needle hub416 housing 479 is provided with at least one projection 480 and/orgroove 481 or vice versa matching with said at least one projection 480and/or groove 481 is provided in an outer wall 458 of the catheter hub412. Thus, the catheter hub 412 is safely secured within the needle hub416 housing 479 by the means of change in dimensions. Alternativearrangements by way of replacing the change of dimensions within thehousing 479 and outer wall 458 of catheter hub 412 can also be employed.

For example, the catheter hub 412 can be snap-fitted in the housing 479of the needle hub 416. The snap-fit may be formed by a protrusion ring484 and a corresponding groove ring 485. The protrusion ring 484 maycomprise at least one groove and the groove ring 485 may comprise atleast one projection or vice versa. The ring of both the projections orgroove can be a continuous ring or a spaced apart formation. Other waysand means for a secure engagement are also encompassed.

As shown in FIG. 4B, the needle guard 426 can include a base portion 444and first 440 and second 442 arms extending from the base portion 444,wherein the first arm 440 is deflected radially outwards by the needle420 against a restoring force when the needle 420 is in its readyposition whereby the needle guard 426 is brought into retaining contactwith the catheter hub 412 by retaining means for retaining the needleguard 426 in the catheter housing 448 as long as the first arm 440 is inits deflected state. The base portion 444 has an axial through-bore 499for receiving the needle 420. The inner diameter of the bore 499 has aclose fit ratio with the outer diameter of the needle 420. The retainingmeans include a first disc-like retaining protrusion 493 provided on thefirst arm 440 and a retaining depression 494 formed in the inner surface456 of the catheter hub 412 and adapted to receive the retainingprotrusion 493.

The disc-like retaining protrusion 493 has the benefit that in the readyposition it is in engagement along a circular contact surface with thecorresponding retaining depression 494 formed in the inner surface 456of the catheter hub 412. This provides an engagement between the needleguard 426 and the catheter hub 412 along a substantial annular portionof the retaining protrusion 493 and the retaining depression 494 whichprovides a safe and reliable engagement between the two components aslong as the needle guard 426 is in its ready position and is to beprevented from being retracted out of the needle hub 416. Even if theneedle guard 426 is rotated within the catheter hub 412, this secureengagement between the catheter hub 412 and the needle guard 426 holdsthe needle guard 426 safely within the catheter hub 412.

Because of a depression 494 being formed in the inner surface 456 of thecatheter hub 412 for retaining the needle guard 426 in particularly theupper end 490 of the needle guard 426 in the housing 448, instead of,e.g., a protrusion, the catheter hub 412 can be manufactured more easilyand, thus, at less manufacturing cost, in particular if the catheter hub412 is a plastic part and, e.g., formed by injection molding. At thesame time the particular design of the first retaining protrusion 493provided on the needle guard 426 ensures effective engagement of theretaining protrusion 493 with the retaining depression 494 and, thus,reliable retaining of the needle guard 426 in the catheter hub 412.Hence, the risk of premature release of the needle guard 426 from thecatheter hub 412 during withdrawal of the needle 420 from the catheterhub 412 and, thus, the risk of accidental pricking by the needle 420 isreduced.

In one embodiment, the retaining protrusion 493 can be of part-circular,in particular semi-circular shape. More specifically, the retainingprotrusion 493 may have generally parallel proximal and distal facesand/or a convex, in particular part-cylindrical, peripheral surface.According to another embodiment, the first retaining protrusion 493 canbe arranged in the region of a distal end 422 of the first arm 440.According to yet another embodiment, a second disk-like retainingprotrusion 495 is arranged on the second arm 442 and adapted to engagewith the retaining depression 494 as long as the first arm 440 is in itsdeflected state. According to yet another embodiment, the second arm 442can be deflected along its entire length radially inwards when theneedle tip 454 is received between the arms 440, 442, to thereby allowthe second retaining protrusion 495 to disengage from the retainingdepression 494.

According to yet another embodiment, the second retaining protrusion 495can be arranged in the region of a distal end 422 of the second arm 442.In particular, the second retaining protrusion 495 may be arrangedopposite from the first retaining protrusion 493. According to yetanother embodiment, the retaining depression 494 is an at leastpart-annular depression, preferably an annular depression.

To explain further, the first arm 440 of the needle guard 426 can belonger than the second arm 442 and has a massive distal wall 418 havingan undercut for catching the needle tip 454. The distal wall 418 isarranged at a distal end 422 of the first arm 440 and extends in adirection transverse to an axial direction A of the needle 420 such thatthe distal wall 418 completely blocks the needle 420. The distal wall418 ensures that the needle tip 454 is prevented from axially projectingout or sideways projecting out of the needle guard 426. The distal wall418 has a bigger dimension than the distal surface of the second arm 442and much bigger dimension than the outer diameter of the needle 420 suchthat the distal wall 418 completely covers and blocks the needle tip 454once confined and entrapped within the needle guard 426. The first andsecond arms 440, 442 of the needle guard 426 extend generally in theaxial direction A from a distal side 460 of the base portion 444, i.e.,generally parallel to the needle shaft 428.

In the ready position, the first arm 440 deflects outward of the needleguard 426 such that the distal wall 418 of the first arm 440 issupported on the needle shaft 428. Further, in this ready position, thefirst and second arms 440, 442 do not engage or interact with an innerwall/surface of the housing 448 prior and during venipuncture of apatient. This non-contact of the first and second arms 440, 442 with theinner surface of the housing 448 significantly decreases the withdrawalforce required and friction caused when a needle 420 is withdrawnthrough a catheter hub 412 being protected by a needle guard 426 afteruse.

Upon withdrawal of the needle 420 from the catheter tube 414 andcatheter hub 412 the needle shaft 428 moves relative to the needle guard426 while the needle guard 426 is retained in the catheter hub 412 untilthe needle tip 454 is received in the needle guard 426. Once the needletip is received in the needle guard 426 the enlargement 496 of theneedle shaft 428 engages with the base portion 444 of the needle guard426 via a stopping element 438 such that the needle guard 426 can bepulled out of the catheter hub 412 together with the needle 420. Anaxial movement of the needle 420 relative to the needle guard 426 is nowlimited, as the distal wall 418 blocks the needle tip 454 axially andthe engagement between the enlargement 496 and the base portion 444 viathe stopping element 438 prevents the needle tip 454 from being removedvia the base portion 444, i.e., the needle tip 454 is safely surroundedby the needle guard 426.

The needle 420 can comprise an engagement means provided at a distancefrom the needle tip 454 for engaging with the needle guard 426 andpreventing the needle guard 426 from sliding off the needle 420.Preferably, the engagement means is formed of by enlargement 496 of theradial dimension of the needle 420 in at least one direction as comparedwith a principal profile of the needle 420. The engagement means can befound by a local crimp, a shoulder, a bulge formed as an annularwidening etc.

As mentioned above, the needle guard 426 can comprise a stopping element438 engaging with the engagement means of the needle 420 when the needletip 454 is received between the first 440 and second 442 arms.Preferably, the stopping element 438 defines an axial bore having across-section adapted to the principal profile of the needle 420 butbeing smaller than the enlargement 496 of the needle 420. Furthermore,the stopping element 438 may be made of a material different from thematerial of the base portion 444, in particular of a metal material. Thestopping element 438 may be of disc-like shape or tubular shape and/orarranged on a distal side 460 of the base portion 444. It can be fixedin the base portion 444 or supported in a floating manner on the needle420.

The catheter assembly 410 is particularly inexpensive to manufacture ifthe base portion 444, the first and second arms 440, 442 of the needleguard 426 are integrally made from a first material. The first materialmay, for example, be a plastic material. Thus, the base portion 444, thefirst and second arms 440, 442 could be manufactured by injectionmolding.

Alternatively, the base portion 444, and one of the first and secondarms 440, 442 can be integrally made from a first material, e.g., aplastic material, and the other one of the first and second arms 440,442 can be made from a second material different from said firstmaterial. For example, said other one of the first and second arms 440,442 can include a strip of material having spring-like properties, e.g.,a strip of sheet metal, providing the above-mentioned inherentelasticity.

The restoring force is created by at least one of an elastic property ofthe first arm 440 and an additional tension element 446. The tensionelement 446, for example, a rubber band or the like, surrounds the firstand second arms 440, 442. The tension element 446 at least partlysurrounding the arms 440, 442 in a region proximal of the firstretaining protrusion 493 or—instead of surrounding the two arms 440,442—biasing the two arms 440, 442 by a linear biasing action.Alternatively or additionally, the first 440 and second 442 arms can bemade of a resilient material having elastic properties.

The construction and shape of the improved intravenous catheter assembly410 according to the various embodiments of the present disclosureprovides a simple configuration. The simple and compact design of theintravenous catheter assembly 410 according to the above disclosure isadvantageous in a clinical setting because it smoothens the wholecatheterization process thereby reducing injury or discomfort to apatient and provides better blood control features. In addition, suchdesign greatly reduces manufacturing costs and is efficient, effectiveand simple in its construction and use.

In the following embodiments, reference will only be made to thespecific new features described therein. The remaining features of thecatheter assembly may be the same as for those in the embodimentsdescribed above and the following describes features may be combinedwith any of the catheter assemblies or other features described herein.

As shown in FIG. 8A, the catheter assembly may include a disc 500arranged proximate to the first valve 471, the second valve 473, or boththe first and the second valve. In the embodiment shown in FIG. 8A, thedisc 500 is arranged proximate to the first valve 471. As describedabove, the first valve 471 or the second valve 473 can be elastomericand be designed to closely conform to the shape of a needle 420 toprevent leaking. The valve can have any geometrical shape and dimension.In a preferred embodiment, the valve can have a dumbbell form as shownin FIG. 8B. In a further preferred embodiment, the valve can have a tubeor barrel form as shown in FIG. 8C. The tube or barrel form can have theadvantage that is easy and cheap to be manufactured. While reference ismade to the first valve 471 in the above discussion, the disc 500 mayalso be arranged proximate to the second valve 473, wherein the sameconsiderations regarding the shape and dimensions apply.

The disc 500 may be arranged in direct contact or close to (i.e., spacedapart from) any of the valves 471, 473. The disc 500 may be arrangedproximal or distal to the valve. The disc 500 may have circular orpart-circular profile, a profile of a C-shape as shown in FIG. 8D, aring-shape (or closed circle, full round shape) as shown in FIG. 8E. orany other shape such as a half-circle (not shown). The disc 500 can beconfigured to hold the valve in its position, for instance due tointeraction of the disc 500 with alignment features in the inner wall ofthe catheter hub. The alignment features may be a recess or grooveformed in the interior surface of the catheter hub, while the disc 500comprises a corresponding projection or protrusion configured to engagethe recess or groove, as may be seen in FIG. 8A. The disc 500 can beconfigured such that at a high pressure, the valve arranged proximate tothe disc 500 does not displace from its position.

As shown in FIGS. 9A and 9B, the proximal end of the catheter hub mayinclude at least one cut 501. The catheter hub 412 may include two cuts501 on opposite sides of the proximal end of the catheter hub. The atleast one cut 501 may be formed by cutting a slit into the proximal endof the catheter hub or by molding the catheter hub to include the cut orslit at a proximal end of the catheter hub. The cut 501 may have arectangular shape as shown in FIG. 9A or any other shape, such as a slitshape or V shape. The cut 501 may support locking of the catheter hub412 with the needle hub 416. The cut 501 may further restrict therotation of the catheter hub 412 with respect to the needle hub 416, forinstance be interacting with corresponding protrusion on the needle hub416. The cut 501 may also be configured to reduce the withdrawal forcerequired to withdraw the needle hub 416 from the catheter hub 412. Thereduction of the withdrawal force may be provided, as the flexibility ofthe proximal end 424 of the catheter hub is increased by the cut 501.

As shown in FIGS. 10A, 10B and 10C, the needle 420 may comprise aproximal needle feature 502 at the proximal end, opposite to the needletip end. The proximal needle feature 502 comprises a deformation thatmay be a needle bend 502A as shown in FIG. 10A, a needle crimp 502B asshown in FIG. 10B or a needle pressing 502C as shown in FIG. 10C. Incase of a needle bend 502A, the needle may comprise only a slight needlebend or a complete needle bend. In case of a needle crimp 502B, theneedle may be crimped at the proximal end with any known method known tothe skilled person. In case of a needle pressing 502C, the needle may bepressed at its proximal end. The proximal needle feature 502 may belocated at a proximal end of the needle hub 416 as shown in FIGS. 10A,10B and 10C. The proximal needle feature 502 may be attached to theproximal end of the needle hub 416 by a needle fixation means 503 suchas glue. The needle fixation means 503 such as the glue may also sealthe proximal needle end. The proximal needle feature 502 can, inaddition to the needle fixation means 503, increase the force requiredto separate the needle 420 from the needle hub 416. In one embodiment,the needle is assembled with the needle hub and then crimped, bend orpressed.

As shown in FIGS. 11A, 11B, 11C and 11D, and as already describedfurther above, the catheter hub 412 may be provided with wings 462 whichin use may be adhesively taped to the skin of the patient at thevenipuncture site to maintain the catheter assembly/device 410stationery during the infusion. While the wings 462 may be integrallyformed with the catheter hub, as shown in FIG. 1 , the followingdescribes separate wings 462 that may be affixed to the catheter hub.

As shown in FIGS. 11A and 11B, the catheter hub 412 may include at leastone wing alignment feature 505 that is configured to interact with atleast one catheter hub alignment feature 506 on the wings 462. The wingalignment feature 505 can be configured to restrict or prevent wingrotation. The wing alignment feature 505 can comprise at least one wingalignment projection 505A extending from the outer surface of thecatheter hub 412. The wing alignment feature 505 may comprise at leastone wing alignment projection 505A. In the embodiment shown in FIG. 11A,the wing alignment feature 505 comprises two wing alignment projections505A extending in opposite radial direction from the outer surface ofthe catheter hub 412 as can be seen in FIG. 11C, The at least one wingalignment projection 505A may be arranged in the same plane as the wingmembers 510, i.e., the wing members 510 extend in a first plane, e.g., ahorizontal plane, and the wing alignment projection or projections 505Aextend in the same plane. The at least one wing alignment projection505A may be configured to prevent distal movement of the wings 462 aswell as to prevent wing rotation. The wing alignment projection 505A maybe in the form of a rib, a nose-like or a ramp-like shape, with itsradial dimension increasing in proximal direction. A proximal face ofthe wing alignment projection 505A can extend in a plane generallyperpendicular to the axial direction, i.e., in a radial plane. Theproximal face of the wing alignment projection 505A can be configured tointeract with a corresponding element of the wings 462 to prevent distalmovement of the wings 462 beyond the wing alignment projection 505A.Side faces of the wing alignment projection 505A extend in a planegenerally parallel to the axial direction. At least one of the sidefaces of the wing alignment projection 505A can be configured tointeract with a corresponding element of the wings 462 to preventrotational movement of the wings 462 beyond the wing alignmentprojection 505A. The wing alignment projection 505A may be integrallyformed with the catheter hub 412.

The wing alignment feature 505 may further comprise a wing alignmentelement 505B. The wing alignment element 505B may include at least oneannular projection 505C extending outwardly from the outer surface ofthe catheter hub 412. In one embodiment, the wing alignment element 505Bmay include two annular projections 505C spaced apart from each other inaxial direction A, thereby forming a annular recess 505D between the twoannular projections. The annular recess 505D may have the same outerdiameter as the outer diameter of the catheter hub, while the twoannular projections 505C have a greater diameter than the outer diameterof the catheter hub. The wing alignment element 505B may further includeat least one lateral projection 505E formed on the annular recess 505Dand connecting the two annular projections 505C in axial direction A.The wing alignment element 505B, including the annular projections 505C,the annular recess 505D and the lateral projection 505E may beintegrally formed with the catheter hub 412.

The wing alignment element 505B may only comprise one annular projection505C provided such that an annular recess 505D, which may have thedimension of the catheter hub, is arranged distal to the annularprojection 505C. This wing alignment element 505B may still comprise alateral projection 505E extending distally from annular projection 505C.

The wing alignment feature 505 may also have no annular projections, butonly include an annular recess 505D having a smaller diameter than theouter diameter of the catheter hub. In this embodiment, the lateralprojection 505E has the same diameter as the outer diameter of thecatheter hub.

Any of the above-described wing alignment elements 505B can beconfigured to guide and orient the wings 462 during assembly of thewings with the catheter hub 412. The wing alignment element 505B mayfurther be configured to prevent wing rotation. The at least one wingalignment projection 505A may be provided on any of the annularprojections 505C, preferably on the distal annular projection 505C.

In one embodiment, the wings 462 may comprise a catheter hub alignmentfeature 506 configured to align and orient with the catheter hub 412.The catheter hub alignment feature 506 may comprise a wing base 506A.The wing base 506A may have a tubular or ring-like body, at a bottompart of which the two wing members 510 extend from. The wing members 510can either be formed integrally with the wing base 506A, or they can beseparate elements that are attached to the wing base. The wing base 506Acan be configured to receive the proximal end of the catheter hub. Thewing base 506A can further be dimensioned to allow passage of thecatheter hub, but to interact with or block the wing alignmentprojection 505A to prevent distal movement of the wings 462 beyond thewing alignment projection 505A.

The catheter hub alignment feature 506 may further comprise a wingsocket 506B. The wing socket 506B may have a semi-circular or half-ringshape and may be provided distal to the wing alignment projection 505A.The wing socket 506B can be configured to interact with the wingalignment projection 505A to prevent wing rotation. Specifically, thewing socket 506B can comprise a top surface that interacts with a sideface of the wing alignment projection 505A. The side face of the wingalignment projection 505A can be configured to interact with the topsurface of the wing socket 506B to prevent rotational movement of thewings 462 beyond the wing alignment projection 505A. The wing socket506B can be integrally molded with the wing base 506A, i.e., the wingsocket 506B can extend in distal direction from wing base 506A.

A slot 506C may be provided between the wing base 506A and the wingsocket 506B. The slot 506C can be configured to receive one of theannular projections 505C of the catheter hub.

The wing base 506A may comprise an indent 506D, for example in the formof a groove or other recess configured to receive the lateral projection505E.

The wing alignment feature 505 may further comprise at least one stopperelement 507. The stopper element 507 can have generally nose-like orramp-like shape, with its radial dimension increasing in distaldirection. A distal face of the stopper element 507 extends in a planegenerally perpendicular to the axial direction, i.e., in a radial plane.The stopper element 507 may be provided on the proximal annularprojection 505C. At least two stopper elements may be provided onopposite sides of the catheter hub. The stopper element 507 may be madeof a resilient material. The stopper element 507 may be configured todeflect to let the wing base 506A pass in distal direction. The stopperelement 507 may further be configured to take its original undeflectedstate after the wing base 506A has passed, thereby locking the wings 462between the stopper element 507 and the wing alignment projection 505A,as shown in FIG. 11C. The stopper element 507 can be resilientlydeformed to allow. The position of the stopper element 507 can be on thesame plane as the wing members 510 and the wing alignment projection505A of the wings 462.

In one embodiment, the catheter assembly comprises a catheter hub 412with a wing alignment feature 505 and wings 462 with a catheter hubalignment feature 506, wherein the wing alignment feature 505 and thecatheter hub alignment feature 506 are configured to align and orientthe catheter hub and the wings with each other. The wing alignmentfeature 505 of the catheter hub comprises two wing alignment projections505A such as two ribs extending in opposite radial direction from theouter surface of the catheter hub 412. The wings 462 comprise a tubularshaped wing base 506A, the distal side of which interacts with the wingalignment projections 505A to prevent distal movement of the wingsbeyond the catheter hub alignment feature 506. The wing alignmentprojections 505A further comprise a wing alignment element 505Bcomprising two annular projections 505C spaced apart and forming anannular recess 505D therebetween, wherein two lateral projections 505Econnect the two annular projections 505C in axial direction A. The twowing alignment projections 505A are arranged on the distal one of theannular projections 505C and extend outwardly therefrom. Further, twostopper elements 507 are provided on the proximal one of the two annularprojections 505C. The two wing alignment projections 505A, the twolateral projections 505E and the two stopper elements 507 are eachprovided on the same plane as the plane of the wing members 510 and onopposite sides of the catheter hub 412. The wings 462 comprise a wingbase 506A with two indents 506D aligned with and configured to receivethe lateral projections 505E. The wings 462 further comprise a wingsocket 506B with a slot having a dimension configured to receive thedistal one of the annular projections 505C. The interaction of the wingalignment feature 505 and the catheter alignment feature 506 providesthat the wings 462 are properly aligned and oriented with the catheterhub 412 and can be safely and easily assembled. Further, the interactionof the wing alignment feature 505 and the catheter hub alignment feature506 provides that the wings 462 cannot move into distal or proximaldirection and cannot rotate with respect to the catheter hub 412 afterassembly.

As shown in FIGS. 12A and 12B, the needle hub 416 may comprise at leastone needle guard engaging element 508 configured to restrict therotation of the needle guard 426. The at least one needle guard engagingelement 508 may be a rib extending from the inner wall of the needle hub416 or extending from the needle guard casing 478 towards the center.The at least one needle guard engaging element 508 may be arranged at abase of the needle hub 416 or needle guard casing 478. The at least oneneedle guard engaging element 508 may be positioned at the lower part483 of the needle guard casing 478. The needle guard may comprise acorresponding needle guard anti-rotation element 509 configured toengage the needle guard engaging element 508,

As shown in FIGS. 13A and 13B, the wings 462 may comprise two wingmembers 510. Each wing member may be made of a soft material, which maybe selected from thermoplastic elastomers (TPE), polyvinylchloride(PVC), isoprene, rubber, ethylenevinylacetate (EVA), and otherelastomeric or resilient materials. Each wing member may be made of arigid material, for instance comprising polypropylene (PP). Each wingmember may also be made of a combination of a soft and a rigid materialselected from the above materials. Each wing member may comprise atleast one through-hole as shown in FIGS. 13A and 13B. The wings 462 mayfurther comprise a window 511 configured for air venting. The window 511may be provided in the bottom part of the wing base 506A connecting thetwo wing members 510.

As shown in FIGS. 14A and 14B, the wings 462 may have a tapered profile.The tapered profile may have an increasing width in proximal direction.The taper may also have a nose-like or a ramp-like shape, with itsradial dimension increasing in proximal direction. The tapered profilecan support the alignment of the device with a patient's body and cansupport the insertion of the needle.

As shown in FIG. 15 , the proximal end 424 of the catheter hub 412 maybe curved and/or tapered. The curved and/or tapered proximal end 424 maysimplify assembly of the catheter hub 412 with the needle hub 416.

As shown in FIG. 16A, and as described in further detail above, thecatheter assembly can comprise a port 464. The port 464 has an opening465 defining an inlet and a bore 466 extending between the inlet and theopening 468 of the inner space 467 of the catheter hub 412. The port 464is covered with a port cap 469. As shown in FIG. 16B, the port mayinclude a port hole 512, The port hole 512 may be provided in the port464. The port hole 512 can contribute in directional flow of fluidthrough the port 464. The port hole profile and location can be changedand the specific position and design of the port hole 512 can beconfigured to optimize the flow and pressure balance.

FIGS. 17A, 17B, 17C, 17D, 17E, and 17F show different configurations ofa valve. The valve may be the first valve 471 or the second valve 473.Corresponding valves are described in further detail in WO 2014/153302,the contents of which are incorporated herein by reference.

The valve described in connection with any of the embodiments herein maycomprise an elastomeric member 513 having a peripheral wall 514projecting from a base surface 515. The base surface 515 can comprise atleast one slit 516, which passes through the thickness of the basesurface 515. The elastomeric member 513 can have a lateral annularprotrusion 517 from edge of the base surface 515 configured to bereceived by a recess (not shown) within an interior wall of the catheterhub. The lateral annular protrusion 517 can support the holding of thevalve in the catheter hub. The lateral annular protrusion 517 may not berequired, for instance in cases in which a disc 500 is provided, asdescribed in further detail above. In addition, the elastomeric member513 can include a vertical annular projection 518 from the base surface515 for providing interference with the catheter hub.

As shown in FIGS. 17A and 17B, the base surface 515 can include an innervertical projection 519 extending from the base surface 515 in thedirection of the peripheral wall 514. The inner vertical projection 519may have a rounded shape, as shown in FIGS. 17A and 17B.

As shown in FIGS. 17C and 17D, the base surface 515 can include a secondvertical projection 520 extending from the vertical annular projection518. The second vertical projection 520 may have a smaller diameter thanthe vertical annular projection 518, as shown in FIGS. 17C and 17D.FIGS. 17E and 17F show a further configuration of the second verticalprojection 520 with a larger diameter.

As shown in FIGS. 18A, 18B and 18C, the valve can comprise at least oneslit 516 in the base surface 515. It is noted that the slits describedherein may also be provided any other valve configurations, e.g., intubular or dumbbell shaped valves, without the other features describedfor the valves in FIGS. 17A to 17F. Specifically, as shown in FIG. 18A,the valve can comprise at least one center slit 516A. The center slit516A may have a Y shape, as shown in FIG. 18A. A center slit 516A cansupport the introduction of the needle in the valve and can beconfigured to seal once the needle is withdrawn. In one embodiment,there may be no flow through the center slit 516A.

Further, as shown in FIG. 18B, the valve can comprise at least one outerslit 516B. The at least one outer slit 516B can form an outer slitprofile, for example made up by four slits at the same distance from thecenter of the valve, which may be have an arc shape, as shown in FIG.18B. An outer slit 516B can contribute towards aspiratory flow, forinstance while drawing blood using a syringe.

Further, as shown in FIG. 18C, the valve can comprise at least onecenter slit 516A and at least one outer slit 516B. For instance, thevalve can comprise one center Y shaped slit and four V shaped slits at asame distance from the center slit, as shown in FIG. 18C.

As shown in FIG. 18D, the center slit 516A can have the form of a hole,a slit, a cross slit, a plus slit, a Y slit, an arc slit, a V slit, orany other shape. The center slit profile may vary with respect to theshape, size, or orientation of the slit. The center slit may be made inany way or process.

As shown in FIG. 18E, the outer slit may have the form of a slit, a Tslit, a Y slit, a V slit, a rounded V slit, an arc slit, or any othershape. The outer slit profile may vary with respect to the shape, size,orientation, location or number of the at least one slit. The at leastone outer slit may be made in any way or process. The valve may compriseany combination of a central slit and outer slits described above.

As shown in FIGS. 19A and 19B, the disc 500 already discussed furtherabove may be joint or linked at a joint 500A to the valve. For instance,in connection with the specific valve configuration described in FIGS.17A to 17F, the disc 500 may extend from the base surface in thedirection of the peripheral wall 514 as shown in FIG. 19A, or may extendfrom the base surface in the opposite direction of the peripheral wall514, to the outside of the valve, as shown in FIG. 19B. It is noted thatthe disc may be joint to any kind of valve, having a differentconfiguration than shown in FIGS. 19A and 19B. For instance, the disc500 may be joint to a valve having a dumbbell shape or a tubular shape,as discussed above. The disc 500 may be made of rigid, a semi-rigid or asoft material. The thickness, the shape and the size of the disc 500 mayvary to optimize the function of the disc in stabilizing the valve andholding the valve in its position. The joint may be made by glue,welding, insert moulding or other means known to the skilled person.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, from the foregoing description, it will be apparent toone of ordinary skill in the art that many changes and modifications canbe made thereto without departing from the spirit or scope of theinvention as set forth in the claims.

Accordingly, it is not intended that the scope of the foregoingdescription be limited to the exact description set forth above, butrather that such description be construed as encompassing such featuresthat reside in the present invention, including all the features andembodiments that would be treated as equivalents thereof by thoseskilled in the relevant art.

The scope of the present invention herein disclosed is not limited bythe particular-disclosed embodiments described above but determined onlyby a fair reading of the appended claims.

LIST OF REFERENCE NUMERALS

-   410 intravenous catheter assembly-   411 a first fluid path-   411 b second fluid path-   412 catheter hub-   412 a first part of catheter hub-   412 b second part of catheter hub-   414 catheter tube-   416 needle hub-   418 distal wall-   420 needle-   422 distal end-   424 proximal end-   426 needle guard-   428 needle shaft-   436 proximal section-   438 stopping element-   440 first arm-   442 second arm-   444 base portion-   446 tension element-   448 housing-   450 distal end section-   452 proximal end section-   454 needle tip-   455 inner wall-   456 inner surface/wall-   457 stepped surface of part 412 a-   458 outer wall/surface-   459 stepped surface of part 412 b-   460 distal side-   461 slip ring-   462 wings-   463 distal section-   464 port/port body-   465 port opening/inlet-   466 bore of the port-   467 inner space of catheter housing-   468 opening of the catheter housing-   469 port/side port-   470 sidewall of catheter housing-   471 first valve-   472 elastomeric septum of first valve-   473 second valve-   474 blood control septum of second valve-   475 plug-   476 chamber-   477 opening of the catheter housing-   478 needle guard casing-   479 inner space/housing of needle hub-   480 projection-   481 groove-   482 upper part-   483 lower part-   484 protrusion ring-   485 ring groove-   486 top portion-   487 bottom portion-   488 bore of needle guard casing-   489 fitment-   490 upper end of needle guard-   491 lower end of needle guard-   493 first disc like retaining protrusion-   494 retaining depression-   495 second disc like retaining protrusion-   496 enlargement-   497 opening-   498 local depression-   499 through-bore-   500 disc-   500A joint-   501 cut-   502 proximal needle feature-   502A needle bend-   502B needle crimp-   502C needle pressing-   503 needle fixation means-   504 needle fixation means-   505 wing alignment feature-   505A wing alignment projection-   505B wing alignment element-   505C annular projection-   505D annular recess-   505E lateral projection-   506 catheter hub alignment feature-   506A wing base-   506B wing socket-   506C slot-   506D indent-   507 stopper element-   508 needle guard engaging element-   509 needle guard anti-rotation element-   510 wing member-   511 window-   512 port hole-   513 elastomeric member-   514 peripheral wall-   515 base surface-   516 slit-   516A center slit-   516B outer slit-   517 lateral annular protrusion-   518 vertical annular projection-   519 inner vertical projection-   520 second vertical projection A axial direction

1. An intravenous catheter assembly comprising: a catheter tube; acatheter hub having a distal end and a proximal end, wherein the distalend is joined to the catheter tube and the proximal end defines ahousing having an inner space; a needle extending through the catheterhub and the catheter tube and defining an axial direction, wherein theneedle has opposite proximal and distal ends, the distal end forming aneedle tip; a needle hub attached to the proximal end of the needle; aneedle guard slidably arranged on the needle, wherein the needle guardis movably retained in the housing of the catheter hub; a valve providedin the inner space in the housing of the catheter hub to prevent foreigncontamination from entering the housing of the catheter hub; and a discthat is arranged in the inner space in the housing of the catheter hubproximal or distal to the valve or that is joint or linked to the valve.2. The intravenous catheter assembly as claimed in claim 1, wherein thecatheter hub defines an inner wall comprising alignment features andwherein the disc is configured to interact with the alignment featuresin the inner wall of the catheter hub.
 3. The intravenous catheterassembly as claimed in claim 2, wherein the alignment features comprisea recess or groove formed in the inner wall of the catheter hub, whilethe disc comprises a corresponding projection or protrusion configuredto engage the recess or groove.
 4. The intravenous catheter assembly asclaimed in claim 1, wherein the proximal end of the catheter hubincludes at least one cut, wherein the needle hub is configured toengage with the at least one cut to support locking of the catheter hubwith the needle hub.
 5. The intravenous catheter assembly as claimed inclaim 1, wherein the needle comprises a proximal needle feature at theproximal end, opposite to the needle tip end, wherein the proximalneedle feature is located at a proximal end of the needle hub
 6. Theintravenous catheter assembly as claimed in claim 5, wherein theproximal needle feature is exposed from the needle hub.
 7. Theintravenous catheter assembly as claimed in claim 1, wherein the needlecomprises a proximal needle feature at the proximal end, opposite to theneedle tip end, wherein the proximal needle feature is attached to theproximal end of the needle hub by a needle fixation means
 8. Theintravenous catheter assembly as claimed in claim 1, wherein theproximal end of the catheter hub is at least one selected from the groupconsisting of curved and tapered.
 9. The intravenous catheter assemblyas claimed in claim 1, wherein the valve comprises an elastomeric memberhaving a peripheral wall and a base surface, wherein the peripheral wallprojects from the base surface, wherein the base surface comprises atleast one slit, which passes through the thickness of the base surface.10. The intravenous catheter assembly as claimed in claim 9, wherein theelastomeric member comprises a vertical annular projection from the basesurface for providing interference with the catheter hub, wherein thevertical annular projection projects from the base surface opposite theperipheral wall.
 11. The intravenous catheter assembly as claimed inclaim 9, wherein the elastomeric member comprises an inner verticalprojection extending from the base surface in the direction of theperipheral wall.
 12. The intravenous catheter assembly as claimed inclaim 10, wherein the base surface comprises a second verticalprojection extending from the vertical annular projection, the secondvertical projection having a smaller diameter than the vertical annularprojection.
 13. The intravenous catheter assembly as claimed in claim 9,wherein the catheter hub defines an inner wall defining a recess andwherein the elastomeric member has a lateral annular protrusionprotruding from an edge of the base surface configured to be received bythe recess within the inner wall of the catheter hub to support theholding of the valve in the catheter hub.
 14. The intravenous catheterassembly as claimed in claim 9, wherein the at least one slit is atleast one center slit configured to seal once the needle is withdrawnand wherein the valve further comprises at least one outer slitconfigured to contribute towards aspiratory flow while drawing bloodusing a syringe.
 15. The intravenous catheter assembly as claimed inclaim 14, wherein the valve comprises at least two outer slits formingan outer slit profile.
 16. The intravenous catheter assembly as claimedin claim 15, wherein the at least two outer slits are equally arrangedfrom at least one selected from the group consisting of each other andthe at least one center slit.
 17. The intravenous catheter assembly asclaimed in claim 14, wherein the at least one center slit has the formof at least one selected from the group consisting of a hole, a slit, across slit, a plus slit, a Y slit, an arc slit or a V slit.
 18. Theintravenous catheter assembly as claimed in claim 14, wherein the atleast one outer slit has the form of at least one selected from thegroup consisting of a slit, a T slit, a Y slit, a V slit, a rounded Vslit or an arc slit.
 19. The intravenous catheter assembly as claimed inclaim 9, wherein the disc is joint or linked at a joint to the valve andextends from the base surface in the direction of the peripheral wall orextends from the base surface in the opposite direction of theperipheral wall, to the outside of the valve.
 20. The intravenouscatheter assembly as claimed in claim 1, wherein the disc is made of arigid, a semi-rigid or a soft material.
 21. The intravenous catheterassembly as claimed in claim 1, wherein the disc has a circular or apart-circular profile, a profile of C-Shape, a ring shape or closedcircle, a full round shape or a half circle.